Phase 2
N=50
Clofarabine, Cytarabine, and G-CSF in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Acute Myeloid Leukemia · Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities · Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) · Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) · Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Bottom Line
View on ClinicalTrials.gov: NCT00602225 ↗Enrolled (actual)
50
Serious AEs
46.0%
Results posted
Sep 2017
Primary outcome: Primary: Maximum Tolerated Dose of Clofarabine — 25 mg/m^2 of clofarabine
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- clofarabine (Drug); cytarabine (Drug); filgrastim (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose of Clofarabine |
25 | — |
| PRIMARY Dose-limiting Toxicity as Assessed by NCI CTCAE v3.0 |
2 | — |
| PRIMARY Response Rates by Cytogenetic Risk Category |
3; 10; 9 | — |
| PRIMARY Response Rates by Cytogenetic Risk Category and Clofarabine Dose |
2; 2; 3; 5; 4; 2 | — |
| PRIMARY Response Rates by Duration First Complete Remission (CR1) |
12; 4; 2; 3 | — |
| PRIMARY Response Rates by Salvage Number |
16; 5; 0 | — |
| SECONDARY Hematologic and Non-hematologic Side Effect Profile |
— | — |
| SECONDARY Efficacy |
12 | — |
| SECONDARY Disease-free Survival |
11 | — |
| SECONDARY Overall Survival |
9 | — |
Summary
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or stopping them from dividing. Colony stimulating factors, such as G-CSF, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.
PURPOSE: This phase I trial is studying the side effects and best dose of clofarabine to see how well it works when given together with cytarabine and G-CSF in treating patients with relapsed or refractory acute myeloid leukemia
Eligibility Criteria
Inclusion Criteria
- ECOG performance status 0-2
- Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent
- Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment
- Male and female patients must be willing to use an effective contraceptive method during the study and for a minimum of 6 months after study treatment
- Serum Total or Direct bilirubin = 1.0 mg/dl, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m^2
- Alkaline phosphatase = = grade 2]), or other organ system dysfunction
- No concomitant cytotoxic therapy or investigational therapy is allowed during the study with the exception of intrathecal therapy for leukemic meningitis; intrathecal therapy must not be given during or within 24 hours of any 5 day Clofarabine/Cytarabine treatment period
- To the extent possible, use of nephrotoxic (e.g., vancomycin, amphotericin B, etc) and hepatotoxic (e.g., voriconazole, cyclosporine, etc) agents is to be avoided during clofarabine; use of alternative medications (e.g., herbal or botanical for anticancer purposes) is not permitted during the entire study period
- Current concomitant chemotherapy, radiation therapy, or immunotherapy other than as specified in the protocol
- More than two failed induction attempts for initial diagnosis or current relapse; for patients enrolled under part III of the protocol, patients must be at first salvage after relapse less than one year from complete remission, or salvage after initial induction chemotherapy
- Allogeneic transplant recipients on immunosuppression or on treatment for GVHD
Data sourced from ClinicalTrials.gov (NCT00602225). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.